[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)
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ClinicalTrials.gov Identifier: NCT01608009 |
Recruitment Status
:
Completed
First Posted
: May 30, 2012
Last Update Posted
: March 10, 2017
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Neoplasm | Drug: Pazopanib and paclitaxel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Pazopanib and paclitaxel |
Drug: Pazopanib and paclitaxel
Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.
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- Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ]Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant
- The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ]Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
- The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of relapsed ovarian cancer
- Responded to at least on one line of prior platinum based therapy
- Relapsed within platinum resistant interval (≤6months)
- Eastern Cooperative Oncology Group (ECOG) performance status of <2
- Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
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Satisfactory baseline haematologic and organ function:
- Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN
- Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN
- Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1
Exclusion Criteria:
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
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Treatment with any of the following anti-cancer therapies:
- radiation therapy 28 days prior to the first dose of pazopanib OR
- surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
- Treatment with anti-angiogenic therapy
- Presence of gross ascites
- Clinically significant peripheral neuropathy
- Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608009
United Kingdom | |
Imperial College Healthcare NHS Trust | |
London, United Kingdom | |
Southend University Hospital NHS Foundation Trust | |
Southend, United Kingdom |
Study Director: | Rohini Sharma, MD | Imperial College London | |
Principal Investigator: | Timothy Crook, MD | Southend University Hospital NHS Foundation Trust |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT01608009 History of Changes |
Other Study ID Numbers: |
CRO1627 |
First Posted: | May 30, 2012 Key Record Dates |
Last Update Posted: | March 10, 2017 |
Last Verified: | March 2017 |
Keywords provided by Imperial College London:
platinum resistant ovarian cancer |
Additional relevant MeSH terms:
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |